Encore Medical, LP recalls Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version:…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Read the official notice →- Date
- 2025-07-02
- Country
- United States
- Brand
- Encore Medical
- Product
- Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version:…
- Classification
- Class II
- Units
- At time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Encore Medical recalls
- 2025-08-20
US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product…
Knee implants contain incorrect labeling (size and/or side incorrect)
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN,…Official notice →- 2025-07-30
US
Encore Medical, LP recalls Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number:…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
FDA · DeviceEncore Medical, LPRFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular,…Official notice →- 2025-07-23
US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
FDA · DeviceEncore Medical, LPU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK,…Official notice →- 2025-01-01
US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC,…Official notice →US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.Official notice →- 2024-01-10
US
Encore Medical, LP recalls Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Mislabeling
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA,…Official notice →
Other drugs & medical recalls in the United States
- 2025-07-02
US
CareFusion 303, Inc. recalls Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main…
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of PR, DE, GU,…Official notice →US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: PT-000664/M009-S-AP. Software Version: all Product…
Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual entry screen if…
FDA · DeviceInsulet CorporationUS market only- Although there are 122823 downloads of the application, our…Official notice →US
RECORDATI RARE DISEASES INC. recalls Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets…
Out of specification stability test result for the Caphosol B solution from process validation lots
FDA · DeviceRECORDATI RARE DISEASES INC.Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and…Official notice →US
Becton Dickinson Infusion Therapy Systems, Inc. recalls REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
FDA · DeviceBecton Dickinson Infusion Therapy Systems, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →US
Jolife AB recalls LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for performing external cardiac compressions on adult patients who have…
Due to demonstration units of chest compression system being provided to a customer which may potentially be utilized for clinical use.
FDA · DeviceJolife ABU.S. Nationwide distribution in the states of IN, MI, OH and TX.Official notice →US
BIGFOOT BIOMEDICAL recalls Bigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H…
Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health risk for people…
FDA · DeviceBIGFOOT BIOMEDICALU.S. Nationwide distribution in the states of AL, FL, GA, IA, IL, NY, PA, TX,…Official notice →